Quality Control Specialist, ELISA

Ossium HealthIndianapolis, IN
6dOnsite

About The Position

We’re looking for a Quality Control Specialist to provide technical support and execution of ELISA testing within Ossium Health’s Quality Control Laboratory, relating to testing of human bone marrow-derived materials for pre-clinical and clinical use. Successful candidates have an understanding of the theory and concepts of ELISA testing. You’ll help to perform in-process testing of clinical samples and validate new methods. This is a great opportunity for detail-oriented individuals looking to further a career in biotechnology and quality systems. This position reports to our Manager, Quality Control.

Requirements

  • BS or BA in biological sciences
  • 2+ years of practical experience performing ELISA testing within a life sciences, biotech, or clinical laboratory environment
  • High level of attention to detail in both operations and documentation
  • Reliable and able to produce consistent, high quality work
  • Great communication skills and organization, able to work as part of a team
  • Great work ethic and positive attitude
  • Strong computer skills, including Microsoft Office
  • Strong attention to detail and observational skills
  • This position is based onsite, full time in our Indianapolis facility
  • Qualified candidates must be legally authorized to be employed in the United States; Ossium is unable to provide sponsorship for employment visa status (eg, H-1B or TN status) for this position, either now or in the future

Nice To Haves

  • Experience working in a CLIA laboratory, cell therapy, tissue banking, blood banking, or other relevant industry experience
  • Experience in testing hematopoietic stem cells
  • Exceptional laboratory technique
  • Understanding of 21 CFR 210, 21 CFR 211, 21 CFR 1271, 42 CFR 493, AATB Standards, and other GMP requirements
  • Strong knowledge of data analysis and statistical methods
  • Hands-on experience in MasterControl, including the quality modules and production records

Responsibilities

  • Perform ELISA tests as operator or verifier in the testing of bone marrow derived products
  • Perform and write method validations and validation reports for new testing procedures
  • Maintain data and documentation related to testing of bone marrow derived products
  • Update product and sample inventory using an electronic inventory system
  • Perform routine and advanced duties required to clean, maintain and operate testing equipment and storage equipment
  • Assist in drafting and revising of departmental procedures
  • Work with coworkers and supervisor to effectively troubleshoot equipment and testing issues

Benefits

  • Competitive salaries
  • Stock options
  • 401(k) matching
  • Medical, dental and vision coverage
  • Four weeks of PTO accrued (vacation & sick time) annually + 11 company holidays
  • Employer paid life insurance and long term disability
  • Gym membership/recreational sports reimbursements
  • Ossium Health provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, protected veteran status, sexual orientation, gender identity, gender expression, or any other protected characteristic.
  • Our Equal Employment Opportunity Policy Statement and the Know Your Rights: Workplace Discrimination is Illegal Poster reaffirm this commitment.
  • Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.
  • If reasonable accommodation is needed, please contact our People Team at [email protected] or 650-285-0603.
  • Ossium Health complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities.
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